PloS one · 2024
Community Health Worker Optimization of Antihypertensive Care in HIV (COACH): Study protocol for a pilot trial of an intervention to improve hypertension care among Tanzanians with HIV.
СтатьяПротокол клинического исследованияПоддержка NIH: внешняя программаНазвание и аннотация: Перевод в очереди
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Min Htike Wai Yan, Manavalan Preeti, Wanda Lisa, Haukila Kelvin, Mmbaga Blandina T, Sakita Francis M, Zebedayo Rennyda, Gwasma Francis, Jafar Tazeen, Bosworth Hayden B, Thielman Nathan M, Hertz Julian T
Аннотация
OBJECTIVE: This study will evaluate the feasibility and preliminary effectiveness of the COACH (Community Health Worker Optimization of Antihypertensive Care in HIV) intervention, which integrates hypertension management into existing HIV care for people living with HIV (PLWH) in Tanzania.
METHODS: The study will be conducted at two HIV Care and Treatment Centers (CTCs) in Tanzania. In a single-arm pre-post feasibility trial, 100 PLWH with hypertension will be enrolled and will receive the six-month intervention. The COACH intervention includes six monthly hypertension educational sessions delivered by community health workers (CHWs) and integrated within HIV CTC visits, monthly blood pressure monitoring, follow up care coordination, fully subsidized antihypertensive medications, a standardized antihypertensive treatment algorithm, and training for providers. The intervention's implementation outcomes will be evaluated using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, and the primary study outcome (reach of the intervention) will be the proportion of all scheduled intervention sessions attended by participants, a measure of feasibility. Secondary clinical effectiveness outcomes will include adherence to antihypertensive medication, blood pressure control, body mass index, cardiovascular risk, and hypertension knowledge.
SIGNIFICANCE: The COACH intervention has the potential to significantly improve hypertension management among PLWH in Tanzania by leveraging the existing HIV care infrastructure and CHWs. This study will provide crucial insights into the feasibility and potential effectiveness of the intervention in integrating hypertension care into HIV services, informing larger-scale implementation and policy changes in Tanzania and other resource-limitted settings.
TRIAL REGISTRATION: Clinical trials.gov Identifer: NCT06503991.
METHODS: The study will be conducted at two HIV Care and Treatment Centers (CTCs) in Tanzania. In a single-arm pre-post feasibility trial, 100 PLWH with hypertension will be enrolled and will receive the six-month intervention. The COACH intervention includes six monthly hypertension educational sessions delivered by community health workers (CHWs) and integrated within HIV CTC visits, monthly blood pressure monitoring, follow up care coordination, fully subsidized antihypertensive medications, a standardized antihypertensive treatment algorithm, and training for providers. The intervention's implementation outcomes will be evaluated using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework, and the primary study outcome (reach of the intervention) will be the proportion of all scheduled intervention sessions attended by participants, a measure of feasibility. Secondary clinical effectiveness outcomes will include adherence to antihypertensive medication, blood pressure control, body mass index, cardiovascular risk, and hypertension knowledge.
SIGNIFICANCE: The COACH intervention has the potential to significantly improve hypertension management among PLWH in Tanzania by leveraging the existing HIV care infrastructure and CHWs. This study will provide crucial insights into the feasibility and potential effectiveness of the intervention in integrating hypertension care into HIV services, informing larger-scale implementation and policy changes in Tanzania and other resource-limitted settings.
TRIAL REGISTRATION: Clinical trials.gov Identifer: NCT06503991.